Abstract: A method of providing ventricular support for a human patient during a high-risk percutaneous coronary intervention procedure includes inserting a mechanical circulatory support device into the vasculature of a human patient. The mechanical circulatory support device being movable between a compressed state and an expanded state. The mechanical circulatory support device is delivered into a heart of the human patient with the aid of a delivery assist device. Operating. The mechanical circulatory support device is operated for a support period. A clinically significant arrhythmia adverse event (AE) associated with the mechanical circulatory support device experiencing the arrhythmia event between the time of vascular access with the mechanical circulatory support device and removal of the mechanical circulatory support device from the vasculature is approximately 2.3%.

Abstract: A method of providing ventricular support for a human patient during a high-risk percutaneous coronary intervention procedure includes inserting a mechanical circulatory support device into the vasculature of a human patient. The mechanical circulatory support device being movable between a compressed state and an expanded state. The mechanical circulatory support device is delivered into a heart of the human patient with the aid of a delivery assist device. Operating. The mechanical circulatory support device is operated for a support period. A clinically significant arrhythmia adverse event (AE) associated with the mechanical circulatory support device experiencing the arrhythmia event between the time of vascular access with the mechanical circulatory support device and removal of the mechanical circulatory support device from the vasculature is approximately 2.3%.

Abstract: A method of providing ventricular support for a human patient during a high-risk percutaneous coronary intervention procedure includes inserting a mechanical circulatory support device into the vasculature of a human patient. The mechanical circulatory support device being movable between a compressed state and an expanded state. The mechanical circulatory support device is delivered into a heart of the human patient with the aid of a delivery assist device. Operating. The mechanical circulatory support device is operated for a support period. A clinically significant arrhythmia adverse event (AE) associated with the mechanical circulatory support device experiencing the arrhythmia event between the time of vascular access with the mechanical circulatory support device and removal of the mechanical circulatory support device from the vasculature is approximately 2.3%.

Abstract: The present invention relates to tissue-supporting medical devices and drug delivery systems, and more particularly to tubular flexible stents that are implanted within a body lumen of a living animal or human to support the organ, maintain patency and/or deliver drugs or agents. The tubular flexible stent has a cylindrical shape defining a longitudinal axis and includes a helical section having of a plurality of longitudinally oriented strut members and a plurality of circumferentially oriented hinge members connecting circumferentially adjacent strut members to form a band. The band is wrapped about the longitudinal axis in a substantially helical manner to form a plurality of helical windings. At least one connector member extends between adjacent windings.

Abstract: A fixed wire dilatation catheter for treating the vasculature of a patient. The dilatation catheter includes an elongated member that has a distal end portion which can be elongated to puncture through blockages within the blood vessels. The dilatation catheter also includes an expandable device located along the elongated member at a location proximal the distal end portion of the elongated member.

Abstract: The present invention relates to tissue-supporting medical devices and drug delivery systems, and more particularly to tubular flexible stents that are implanted within a body lumen of a living animal or human to support the organ, maintain patency and/or deliver drugs or agents. The tubular flexible stent has a cylindrical shape defining a longitudinal axis and includes a helical section having of a plurality of longitudinally oriented strut members and a plurality of circumferentially oriented hinge members connecting circumferentially adjacent strut members to form a band. The band is wrapped about the longitudinal axis in a substantially helical manner to form a plurality of helical windings. At least one connector member extends between adjacent windings.

Abstract: A fixed wire dilatation catheter for treating the vasculature of a patient. The dilatation catheter includes an elongated member that has a distal end portion which can be elongated to puncture through blockages within the blood vessels. The dilatation catheter also includes an expandable device located along the elongated member at a location proximal the distal end portion of the elongated member.

Abstract: A tri-leaflet prosthetic cardiac valve with leaflets having an analytic shape in a selected position. The leaflets are connected to a valve body at attachment curves. The shape of the leaflet is selected from a set of geometries that can be represented mathematically. The attachment curve is selected to improve the durability of the tri-leaflet valve by moving the point of maximum loaded stress along the attachment curve away from the commissures. An inner wall of the valve body is given a non-circular shape near the attachment curve, the shape of the inner wall corresponding to the attachment curve. Also, a method of making a valve by selecting an analytic leaflet shape, selecting an attachment curve to improve durability of the valve by moving the point of maximum loaded stress along the attachment curve away from the commissures, and forming a valve body to support one or more leaflets, the valve body having a non-circular inner wall conforming to the attachment curve.

Abstract: A heart valve having a sewing ring marked by six radially spaced marks. The marks may be spaced at regular intervals around the sewing ring, or they may correspond to asymmetric features of the valve, such as commissures supporting differently sized leaflets. Some of the marks may be placed at a midpoint between adjacent commissures. A template for temporary placement at an implantation site within the patient's heart has six radially spaced marks, corresponding to the marks on the sewing ring.

Abstract: A method whereby one or more occluders are inserted in the housing of a prosthetic heart valve by compressing the housing of the prosthetic heart valve at four discrete locations, thereby causing the housing to deform sufficiently for insertion of occluders between diametrically opposed pivot supports on the inner surface of the housing. The appropriate locations for application of the compressive forces are identified. Compression force is then applied using either pin blocks or v-shaped blocks. One or more occluders are inserted in the pivot supports. The compressive forces are released, allowing the housing to return to its unstressed generally annular shape and securing the occluders in the housing.